03. 07. 2019 | Back to news overview
Updated ASCO Guidelines Establish TAILORx-defined Cutoffs for Determining Chemotherapy Benefit with the Oncotype DX Breast Recurrence Score® Test in Node-negative Breast Cancer. New ASCO Recommendations Increase Proportion of Women Who Can Be Spared Chemotherapy Based on Landmark TAILORx and NSABP B-20 Randomized Clinical Trials.
Oncotype DX Breast Recurrence Score® test and the TAILORx results have been recommended to guide chemotherapy treatment use in patients with node-negative early-stage breast cancer by the American Society of Clinical Oncology (ASCO) in its 2019 Guidelines for Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy. Using the strong and highest level of evidence from TAILORx, the updated ASCO guidelines increase the proportion of women who can be effectively treated without chemotherapy based on the Oncotype DX® results, highlighting the importance of testing all medically eligible patients as standard of care.
"We are pleased that the ASCO guidelines have been updated to reflect the findings from the landmark TAILORx trial, the practice-changing results of which demonstrated that the Oncotype DX Recurrence Score result can be used to guide chemotherapy decision-making for all medically eligible women with the most common form of early-stage, invasive breast cancer," said Steven Shak, M.D., chief scientific officer, Genomic Health. "The TAILORx results have influenced positive treatment guideline recommendations from ASCO and other organizations around the world, elevating the Oncotype DX test to a new global standard of care."
TAILORx, sponsored by the National Cancer Institute (NCI) and conducted by the ECOG-ACRIN Cancer Research Group, involved 10,273 women across 1,100 trial sites in six participating countries. The study results, which were presented during the Plenary Session at the 2018 ASCO Annual Meeting last June and simultaneously published in The New England Journal of Medicine, demonstrated that the Oncotype DX Breast Recurrence Score test definitively identifies the vast majority of women with early-stage breast cancer who receive no benefit from chemotherapy, and the important minority of women for whom chemotherapy benefit can be life-saving. Patients with an Oncotype DX Breast Recurrence Score result of 25 or less – up to about 80 percent of patients – may be safely spared chemotherapy and its well-known side effects, while those with scores of 26 to 100 may receive a life-saving benefit from chemotherapy.
"The updated ASCO breast cancer treatment guidelines based on the TAILORx results will provide physicians with clarity and confidence that they are selecting the right treatment for each of their breast cancer patients," said Harold A. Burstein, M.D., Ph.D., medical oncologist at the Dana-Farber Cancer Institute. "Having guidelines that reflect the latest ground-breaking research is critical in ensuring that physicians incorporate standard-of-care technology, such as the Oncotype DX test, when making clinical decisions about treatment for their patients with breast cancer."
2019 Guidelines for Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy